The federal court in New Jersey recently granted summary judgment to a drug manufacturer in a failure to warn claim under Texas law. See Solomon v. Bristol-Myers Squibb Co., No. 07-1102 (D.N.J., 1/3/12). The opinion offers a number of useful observations.

The case involved Plavix, a drug that inhibits blood platelets from forming clots. The drug is often used in patients with recent heart attack, stroke, or diagnosed peripheral vascular disease, to prevent dangerous clots.Taking Plavix, like any medicine, is not without risk. Because it functions by inhibiting the formation of blood clots, Plavix increases the risk of bleeding. The manufacturer warned of this risk extensively on the label.

In November 2002, Plaintiff suffered a heart attack, and his doctors placed two metal stents in his arteries to maintain blood flow to his heart. At that time, one of his doctors prescribed Plavix with aspirin in order “to prevent clots.” Subsequently, Plaintiff’s treating cardiologist continued this prescription. In July 2005, Plaintiff began suffering gastrointestinal bleeding, which led him to sue Defendants asserting product liability related causes of action, under Texas state law, for defective design, manufacturing defect, failure to warn, and negligence. All these claims essentially turned on whether Defendants adequately warned that Plavix carried a risk of bleeding complications.

Defendants moved for summary judgment, relying in large measure on the learned intermediary doctrine. Readers will recall that within the prescription drug context, where a plaintiff sues the manufacturer of a prescription drug for failing to adequately warn of the drug’s effects, Texas courts employ the learned intermediary doctrine. As the Texas Supreme Court has explained, the underlying premise for the learned intermediary doctrine is that prescription drugs are complex and vary in effect, depending on the unique circumstances of an individual user, and for this reason, patients can obtain them only through a prescribing physician. Indeed, a patient’s doctor, who stands between the patient and the drug manufacturer, is in the best position to professionally evaluate the patient's needs, assess the risks and benefits of available drugs, prescribe one, and supervise its use. Hence, if the doctor is properly warned of the possibility of a side effect and is advised of the symptoms normally accompanying the side effect, it is anticipated that injury to the patient will often be avoided. Recognizing the doctor-patient relationship, the doctrine excuses a drug manufacturer from warning each patient who receives the product when the manufacturer properly warns the prescribing physician of the product’s dangers.

In arguing the warning claim, Plaintiff contended that he was entitled to a heeding presumption that proper warnings would have a made a difference and that this presumption excused him from proving causation. However, Texas law creates no such presumption. The Fifth Circuit has noted that neither Texas nor federal courts applying Texas law have applied the read-and-heed
presumption to pharmaceutical cases involving learned intermediaries. Indeed, Texas has explicitly rejected the Restatement (SECOND) Of Torts § 402A, Comment j's read-and-heed presumption for policy reasons and, said the court, because it has been superseded by Restatement (THIRD) Of Torts::Products Liability § 2.

On the factual assertions of failure to warn, the court found that although Plaintiff presented various studies and articles challenging the efficacy of Plavix in certain types of patients, none of those studies were relevant to Plaintiff’s medical situation. For example, the studies upon which Plaintiff tried to rely regarding Plavix’s alleged ineffectiveness for patients 75 years or older had no relevance since Plaintiff was well under 75 years old when he stopped taking the drug. More fundamentally, many of Plaintiff's arguments seemed to center on an alleged lack of efficacy; Plaintiff’s efficacy arguments were not relevant in the context of a failure-to-warn analysis. Plaintiff’s claim was essentially premised on the fact that he suffered substantial bleeding, while his response to the motion argued Plavix did not work. A proper warning should adequately alert any danger or harm that may result from ingesting the drug; efficacyis a separate issue. Permitting Plaintiff to pursue his failure-to-warn claim on an efficacy theory would, as has been found in other jurisdictions with similar laws, impermissibly expand liability under Texas law on the adequacy of pharmaceutical warning labels.

Focusing on the alleged inadequacy of the warning, Texas law is clear that when a warning appropriately and specifically mentions the circumstances complained of, the warning is adequate as a matter of law. First and foremost, said the court, the warning label here clearly cautioned users that PLAVIX use with aspirin was associated with an increase in bleeding. Plaintiff failed to provide any evidence to show that the risk levels published on the Plavix warning label were inaccurate, insofar as the warnings concerned the risk of bleeding.

Another ground for summary judgment. In addition to proving inaccuracy, Plaintiff had to show that
the allegedly defective warning label was the producing cause of Plaintiff’s injury. Thus, it was Plaintiff’s burden to demonstrate that the treating physician would not have used or prescribed the product but for the inadequate warning. However, the cardiologist insisted that despite the risks, it was important that these drugs were prescribed to Plaintiff to prevent a life-threatening problem. The doctor acknowledged that the therapy could cause serious risk of bleeding in patients. Nevertheless, the cardiologist insisted that despite the risks, it was important to prescribe the drug. Furthermore, throughout the prescribing doctor's deposition, he consistently testified that he did not rely on Plavix warning labels. Texas law is clear on causation: when the prescribing physician is aware of the product’s risks and decides to use it anyway, any inadequacy of the product’s warning, as a matter of law, is not the producing cause of the patient’s injuries. It was clear that the doctors were aware of the serious risks of bleeding when placing Plaintiff on the medicine.

Plaintiff’s failure-to-warn claim failed for the additional reason that, under Texas law, Defendants are presumed not liable because the Plavix warning labels were approved by the FDA. In Texas, where prescription drug manufacturers comply with the FDA regulations, Texas law creates a rebuttable presumption of non-liability in prescription drug suits. See Tex. Civ. Prac. & Rem.
Code. Ann. § 82.007.

A federal court in Ohio recently ruled that a plaintiff who used only the generic form of the drug metoclopramide has no cause of action under the Ohio Product Liability Act against makers of the brand-name drug. Hogue v. Pfizer Inc., No. 10-805 (S.D. Ohio, 9/27/12).

In late 2000, Ms. Hogue's physician prescribed Reglan® to treat plaintiff''s abdominal pain and digestive problems. Ms. Hogue then began to take generic metoclopramide and continued to do so until about August 2009. The parties stipulate she ingested only the generic version of metoclopramide, which the Brand Defendants did not manufacture. She later allegedly suffered side effects and sued both the branded and the generic manufacturers for an alleged failure to warn. And so we have two rulings to reflect the status of each kind of defendant.

The generic defendants filed a motion to dismiss, arguing that the United States Supreme Court held in PLIVA, Inc. v. Mensing that such state law tort claims against generic drug manufacturers are preempted by federal law. Generic defendants pointed out that the Mensing case involved the same generic medication at issue in this case, the same alleged injuries, some of the same generic drug manufacturer defendants, the same claims, etc. Plaintiff argued that nonetheless the Mensing holding was somehow more limited. The court agreed with the defendants: First, the Supreme Court rejected the theories that generic drug manufacturers could use the "changes-being-effected" ("CBE") process to change their labels to satisfy the state law. The FDA interprets the CBE process to allow generic manufacturers to change generic drug labels only to match an updated brand-name label or to follow the FDA's instructions. Any unilateral change to labels by generic drug manufacturers would violate the federal requirement that generic drugs be identical to brand name drugs in both substance and labeling.

Second, the court noted that the Supreme Court has considered and rejected the plaintiff's argument that the generic drug manufacturers could have sent "Dear Doctor" letters as additional
warnings. Dear Doctor letters qualify as "labeling" and therefore must be consistent with, and not
contrary to, the rest of the drug's approved labeling. Any Dear Doctor letter containing substantially new warnings would not conform to the approved labeling. Moreover, if generic drug
manufacturers, but not the brand-name manufacturer, sent such letters, that would inaccurately imply a therapeutic difference between the branded and generic drugs and thus could be impermissibly misleading.

Third, the Supreme Court already considered whether the generic drug manufacturers could have complied with the state laws by proposing stronger warning labels to the FDA. Even assuming such a duty exists on the part of generics, which is not clear, fulfillment of that duty would not have satisfied the state law requirements. Because it was impossible to comply with both federal law and state law, the plaintiff's state law claims were preempted.

Plaintiff further argued that Mensing didn't apply when the FDA has designated a defendant's drug as a reference listed drug ("RLD"). But the designation of a drug as an RLD does not change the manufacturer's status as an Amended New Drug Application ("ANDA'') holder, the RLD designation does nothing to alter an ANDA holder's duties concerning labeling changes.

On the legal side, even if a failure to warn was preempted, plaintiff argued that several of her legal claims were not based on a theory of failure to warn. For example, plaintiff stated her breach of warranty claims did not conflict with any federal requirement regarding labeling and thus were not preempted. But the required analysis here is to focus not on the label or caption of the count, but the substance of the claim; and the other claims such as breach of warranty were in fact predicated on the failure to provide adequate warnings and were preempted. See also Smith v. Wyeth, 657 F.3d 420, 423 (6th Cir. 2011 ), cert. denied 132 S. Ct. 2103.

Brand defendants moved for summary judgment, arguing that Ohio law requires a plaintiff to prove the defendant manufactured the product that caused her injuries. Because they did not manufacture the metoclopramide Ms. Hogue ingested, her claims against them should fail as a matter of law.

The court noted that under Ohio law the defendant must have sold the actual product that was the cause of harm for which the claimant seeks to recover compensatory damages, and proof that a manufacturer designed or sold the type of product in question is not proof that the manufacturer did so for the actual defective product in the product liability claim. The Ohio Product Liability Act displaced plaintiff's common law claims, and required plaintiff to prove the defendant manufactured the product that caused her injuries. They did not, so summary judgment was warranted.

A New Jersey federal court granted summary judgment last week to a pharmaceutical defendant in a failure to warn case. See Baker et al. v. APP Pharmaceuticals LLP et al., No. 3:09-cv-05725 (D.N.J.). The case should be interesting to our readers in part because there really isn't a huge amount of law on warning causation in the busy jurisdiction of New Jersey.

During a hospital stay, plaintiff Baker was administered the commonly prescribed drug heparin. Heparin is an anticoagulant: it prevents blood clots. The opinion noted that the drug is associated with heparin induced thrombocytopenia (“HIT”), or low blood platelet count. HIT may in a few patients progress to a more serious adverse reaction called heparin induced thrombocytopenia and thrombosis (“HITT”). Plaintiff received heparin during and after her surgery, and a few days later her platelet count was down; but according to the opinion it was not known at what point her platelet count reached serious levels because no one measured her platelet level for several days, despite the hospital’s stated protocol to monitor a patient’s platelet count periodically in order to detect possible HIT.

Plaintiff suffered injury to her left foot and leg, and thereafter sued several manufacturers of heparin, asserting they failed to adequately warn of the serious side-effects associated with heparin use. The parties agreed that defendant’s heparin has always contained FDA-approved labeling, including risk disclosures and warnings. In 2001, the heparin label specifically disclosed the risk of HIT and HITT in the “Precautions” section. In 2005, defendant submitted a supplemental NDA via the “changes being effected” process to include additional HIT and HITT information the “Warnings” section of its heparin labeling. See 21 C.F.R. 314.70. The FDA suggested several alterations, all of which defendant incorporated into the labeling, and the FDA found the updated labeling “acceptable” in June 2007.

In New Jersey, product liability actions are governed by the New Jersey Products Liability Act (“PLA”). N.J. Stat. Ann. §2A:58C-1, et seq. Under the PLA, in failure to warn cases involving prescription drugs, if the warning or instruction given in connection with a drug has been approved or prescribed by the FDA, there is a rebuttable presumption that the warning is adequate. This is no ordinary rebuttable presumption, remarked the court. Compliance with FDA regulations gives rise to “what can be denominated as a super-presumption.” Kendall v. Hoffman-La Roche, Inc., 36 A.3d 541, 544 (N.J. 2012). Indeed, the PLA’s presumption that an FDA-approved prescription drug label is adequate “is stronger and of greater evidentiary weight than the customary presumption referenced" in the rules of evidence. Bailey v. Wyeth, Inc., 37 A.3d 549, 571 (N.J. Super. Ct. Law Div. 2008), aff’d sub nom. Deboard v. Wyeth, 28 A.3d 1245 (N.J. Super Ct. App. Div. 2011).

In this case, there is no dispute that the heparin labeling was approved by the FDA. Therefore, defendant was entitled to the statutory presumption that its heparin labeling satisfied its duty to warn. Plaintiff tried to rebut the presumption, first, with allegations of deliberate concealment or nondisclosure of after-acquired knowledge of harmful effects by the pharmaceutical company, and second with allegations of an economically-driven manipulation of the post-market regulatory process. See McDarby v. Merck & Co., Inc., 949 A.2d 223, 256 (N.J. Super. Ct. App. Div. 2008).

However, significantly, all of the information plaintiff accused defendant of withholding was publicly available in published scientific and medical literature. And defendant did in fact disclose much
of what plaintiff claimed was deliberately concealed or withheld. For example, when submitting its proposed updated label to the FDA in 2005, Baxter included several scientific articles and a number of adverse event reports relating to HIT and HITT. As to the second rebuttal effort, plaintiff offered no real evidence that Baxter rejected the FDA’s proposed changes to heparin labeling, or asked pharmaceutical representatives to avoid discussing HIT and HITT when speaking to physicians, or manipulated the conclusions of heparin clinical trials, or did anything sufficient to "manipulate" the regulatory process.

The more interesting part of the opinion arises from the fact that even if a plaintiff is able to demonstrate that a prescription drug’s warning is inadequate, that plaintiff still must prove that the inadequate warning proximately caused her injury. See Campos v. Firestone Tire & Rubber Co., 485 A.2d 305, 311 (N.J. 1984). “To satisfy this burden, a plaintiff must show that adequate warnings would have altered her doctors’ decision to prescribe.” Strumph v. Schering Corp., 606 A.2d 1140 (N.J. Super. Ct. App. Div. 1992) (Skillman, J., dissenting), rev’d 626 A.2d 1090 (1993) (adopting Judge Skillman’s dissent).

The court noted that “a heeding presumption may be applicable to claims of failure to warn of the dangers of pharmaceuticals.” McDarby, 949 A.2d at 267. A heeding presumption allows one to presume that the plaintiff’s physician would not have prescribed the drug to the plaintiff if there had been an adequate warning; in other words, the plaintiff’s physician would have heeded the adequate warning. The heeding presumption is rebuttable and can be rebutted if the plaintiff’s physician was aware of the risks of the drug that he prescribed, and having conducted a risk-benefit analysis, nonetheless determined its use to be warranted. Also. a manufacturer who allegedly fails to warn the medical community of a particular risk may nonetheless be relieved of liability under the learned intermediary doctrine if the prescribing physician either did not read the warning at all, or if the physician was aware of the risk from other sources and already considered the risk in prescribing the product. In that context, the physician’s conduct is the superseding, intervening cause that breaks the chain of liability between the manufacturer and the patient.

Here, the doctor stood by his decision to administer heparin to Mrs. Baker. She required heparin by standard medical procedure, and well documented clinical knowledge, at several different points during her operation and for several different reasons, he opined. Since he was aware of the risks of the drug that he prescribed and, having conducted a risk-benefit analysis, nonetheless determined its use to be warranted, the presumption was rebutted as a matter of law.

Moreover, the prescriber testified in his deposition that he does not read the label of drugs he frequently prescribes, which includes heparin. Therefore, a different warning would not have made a difference in plaintiff's treatment or outcome because there was no evidence he would have reviewed it.

Finally, there was a third causation problem; the opinion notes that it was undisputed that, despite doctors orders, the Hospital failed to follow its own heparin treatment protocol. Had that monitoring occurred, Mrs. Baker’s physicians would have discovered the onset of HIT sooner. Plaintiff's own expert admitted that her injuries “would have been substantially mitigated” with a “good chance of avoiding" them. Therefore, plaintiff failed to raise a genuine issue of material fact that it was the heparin labeling, as opposed to the conduct of the hospital, that caused her injury.

Many people consider "The Natural" to be one of the greatest sports movies of all time, and those that think deep thoughts have asserted that the screenplay (presumably not the 1952 book too?) was based in part on the story of Sir Percival from the Arthurian myths, with the broken bat "Wonderboy" taking the part of the knight's broken sword. Had Roy Hobbs used an aluminum bat, that aspect of the story would have been lost. Since their introduction in the early 1970's, aluminum bats have become quite popular in youth and amateur adult baseball and softball markets. The new bats are often touted as having a wider sweet spot, more power, better feel, or higher performance. It is pretty much accepted that balls come off metal bats faster than they do from wood bats, but this aspect of performance has fueled an ongoing metal/wood issue in some circles.

While pitching in an American Legion baseball game on July 25, 2003, the eighteen year-old plaintiff was struck in the head by a batted ball that was hit using H&B’s model CB-13 aluminum bat. Tragically, plaintiff died from his injuries. In 2006, Brandon’s parents sued H&B, claiming H&B’s model CB-13 aluminum bat was in a defective condition because of the alleged enhanced risks associated with its use: It increased the velocity speed of a batted ball when it left the bat, thus decreasing infielders’ reaction times, which allegedly resulted in a greater number of high energy batted balls in the infield.

The matter was tried in October, 2009, and the design defect and failure to warn claims were submitted to the jury, which concluded that the model CB-13 aluminum bat was not designed defectively, but determined the bat was in a defective condition due to H&B’s failure to warn of the enhanced risks associated with its use. They awarded plaintiffs an $850,000 verdict on their failure to warn claim. Defendant appealed.

The key issue was whether a failure to warn claim can be brought by a bystander -- plaintiff was not the consumer nor the user. H&B asserted that only the individual batting (actual user) and the individual who purchased the bat (actual consumer) could assert a failure to warn claim. The court disagreed, saying this interpretation of the terms user and consumer is somehow contrary to the definition of the terms as contained in the Restatement (Second) of Torts § 402A. This state court’s products liability jurisprudence had recognized that a failure to warn claim may be brought by some persons who are not actual purchasers or users of a product; previous plaintiffs included those who are passively enjoying the benefit of the product, as in the case of passengers in automobiles or airplanes, as well as those who are utilizing it for the purpose of doing work upon it. "The realities of the game of baseball" supported, said the court, the decision to submit the failure to warn claim to the jury. The bat was deemed an indispensable part of the game. The risk of harm accompanying the bat’s use extends beyond the user, beyond a player who holds the bat in his or her hands. A warning of the bat’s risks to only the batter standing at the plate inadequately communicates the potential risk of harm posed by the bat’s increased exit speed, concluded the court. In this context, all of the players, including plaintiff, were deemed "users or consumers" placed at risk by the increased exit speed caused by H&B’s bat.

Defendant also argued that plaintiff could not establish causation - reading and heeding the warning. The court held that H&B’s argument erroneously assumed that placing a warning directly on the bat is the only method to provide a warning. While placing a warning directly on a product is certainly one method of warning, other methods of warning exist, including, but not limited to, issuing oral warnings and placing warnings in advertisements, posters, and media releases. Davis v. Wyeth Laboratories, Inc., 399 F.2d 121, 131 (9th Cir. 1968) (“[O]ther means of communication such as advertisements, posters, releases to be read and signed . . . or oral warnings . . . could easily have been undertaken . . . .”). Such warnings, if issued by H&B in this case, said the court, could have communicated to all players the potential risk of harm associated with H&B’s bat’s alleged increased exit speed.

What the court here called a "flexible" approach to causation really eviscerates one of the fundamental elements of the claim. The court allowed the jury to infer without any basis in fact that plaintiff would have heeded a warning had one been given-- apparently because he was deceased, and thus real proof of causation was hard to find. There is no basis to allow a jury simply to express sympathy for a tragic accident victim,as here there was not sufficient proof that the plaintiff would have adjusted his behavior after receiving the warning to avoid the injury. The decision puts this court in a tiny minority of states that recognize some kind of bystander failure to warn liability, which most courts agree is unworkable and contrary to the reality of modern commerce.

The concurrence correctly noted that plaintiff did not articulate specifically what a warning should have contained and what message should have been given. Statements to the effect that the bat would hit balls at unusually fast speeds or unusually far distances are the kind of messages accompanying usual product advertising and are not likely to change a player's/plaintiff's behavior. Moreover, they are precisely the qualities in a bat which baseball teams and players seek out. Plaintiff could not articulate specifically how a warning would have changed the result here, in other words, how the failure to warn caused this accident.

H&B also argued that because plaintiff had been hit by batted balls before, he knew he could be hit and, therefore, assumed the risk when he continued playing baseball. The court explained that assumption of the risk defense in this state is inapplicable as a matter of law without evidence the victim actually knew he or she would suffer serious injury or death, and, knowing that, the victim voluntarily exposed himself or herself to the danger. Lutz v. Natl. Crane Corp., 267 Mont. 368, 379-80, 884 P.2d 455, 461-62 (1994). What the victim actually knew is evaluated using a subjective standard in Montana. Here, said the court, there was no evidence that plaintiff actually knew he would be seriously injured or killed when pitching to a batter using one of H&B’s model CB-13 aluminum bats. He knew he could be hit with a screaming line drive, but not that it could injure him seriously?

Plaintiff's apparent theory, as articulated in closing argument, was that H&B should have
advertised that its bat “could kill.” And the inference which plaintiff asked the jury to draw in order to establish causation was that, following the publishing of a warning “that this bat could kill,” the parents would have prohibited Brandon from playing baseball. That tells you how unworkable the theory is. This was a terrible accident on a baseball field, the kind of accident that has also occurred with wood bats. The bat was not defective. It was made in accordance with the rules approved for play by baseball's organizing and governing bodies. Bad facts again make bad law.

Plaintiff Christopher Walkowiak began working for a special effects company in the movie industry in 1994. His boss had a Class 1 Pyrotechnic Operator license, and Walkowiak received on-the-job training in special effects. He obtained a Class 3 Pyrotechnic Operator license in 1995 and a Class 2 license in 1998. In order to obtain these licenses, Walkowiak had to obtain references from pyrotechnicians and pass a written examination. The written examination was general in nature and did not cover every specific types of explosive device used in productions.

Defendant MP Associates (MP) manufactures pyrotechnic devices. Defendant Roger George Rentals (RGR) rents and sells special effects supplies, including pyrotechnic devices manufactured by MP. Its primary clientele is the entertainment industry. One of the products they sold was a simulated stinger missile (SSM). The SSM consists of a cardboard tube with a red plastic cap on one end and a white plastic cap on the other end. The tube contains pyrotechnic materials near the end with the red plastic cap. Prior to ignition, the white plastic cap is to be removed. Upon ignition, a pellet of pyrotechnic material is propelled out of the end of the tube by gunpowder. It produces bright white light and smoke, and it travels about 200 feet. It simulates the appearance of a missile. Pretty clever, and can fool the camera.

The SSM had a sticker on the side of the cardboard tube which read, “Dangerous. Handle With Care. Keep Fire Away.” This was a standard warning that MP placed on all of the pyrotechnic devices it sold. The SSM also had a piece of tape over the white plastic cap which read, “Remove Before Ignition. This Side Up.” Once the tape was removed, there was nothing on the SSM to indicate which end was to face up. Packaging materials which came with the SSM included a list of “Dos and Don’ts” which applied to pyrotechnic devices in general. The list included the warning not to “use any explosive material unless completely familiar with safe procedures for their use, or under the direction of competent, experienced persons.” However, the packaging materials did not include any specific instructions for use of the SSM. The manufacturer sold SSMs only to purchasers with a Class 1 or Class 2 Pyrotechnic Operator license. And the company would personally discuss use of the SSM with the purchaser. Since 1998, MP had reportedly sold over 20,000 SSMs. Until the accident in this case, there had been no misfires or injuries resulting from the use of an SSM.

On January 18, 2007, Walkowiak was working on the movie set for “Charlie Wilson’s War.” His supervisor instructed Walkowiak to test fire an SSM that had been leftover from a previous production, using the same shoulder launcher that had been used in “Over There.” The shoulder launcher consisted of a steel tube bolted to a rifle stock. The steel tube was closed at the end bolted to the rifle stock. The SSM was loaded into the open end of the steel tube. It was fired by means of a battery-operated power switch which was connected to the SSM by wires. Walkowiak’s Class 2 license allowed him to use the SSM fired from a shoulder launcher under the supervision of a Class 1 license holder.

But Walkowiak had not worked on “Over There.” He had never fired an SSM before or seen an SSM loaded into a shoulder launcher. He had not seen any instructions for using the SSM. What he did know was that the SSM was a controlled pyrotechnic device that was potentially dangerous. He knew that he should get questions regarding its use answered before using it. Walkowiak called one of the defendants and asked how to operate the shoulder launcher. Defendant told him how to wire and prepare the launcher. He did not tell Walkowiak how to load the SSM into the launcher, however. Before loading the SSM into the shoulder launcher, Walkowiak saw tape with printing on one end of the SSM. He did not recall seeing the words “Remove Before Ignition” or “This Side Up” on the tape. However, he understood these words to mean that the cap and tape should be removed before discharging the SSM, and “This Side Up” referred to the discharge end of the SSM.

Walkowiak removed the cap and the tape from the SSM. Walkowiak made the decision as to how to load the SSM into the shoulder launcher. Walkowiak loaded the SSM into the shoulder launcher and connected the wires. He believed he was loading the device safely and correctly. He knelt down and pointed the shoulder launcher toward a wall. After a countdown, Walkowiak fired the device. There was an explosion and a bright flash of light. The SSM exploded in the steel tube. The steel tube broke off the rifle stock and hit Walkowiak in the face, causing severe injury. It was determined that he had loaded the SSM in backwards.

Plaintiff sued the various parties in the chain of distribution of the SSM. The trial court dismissed the claim. The trial court explained that merely because an accident has occurred, there is no presumption of a defect or negligence. In this case, Walkowiak had not shown that the device had any physical, manufacturing or design defect. There was no evidence of even a single incident where the device was used properly but caused this kind of injury. Therefore, the trial court noted, the only potential basis for imposing liability on defendants was the breach of a duty to warn of a danger. The court added, however, that product liability cannot be based on failure to warn of a danger that is known or obvious to a user, under California law. Failure to warn of a danger that is generally known and recognized does not, by itself, render a product dangerous.

Plaintiff appealed. The court of appeals discussed the doctrine of sophisticated user. In explaining the development of the sophisticated user defense, the state Supreme Court had begun with the general principle that manufacturers have a duty to warn consumers about the hazards inherent in their products. This enables consumers to avoid the hazards through careful use of the products or refraining from using the products altogether. However, the sophisticated user defense exempts manufacturers from their typical obligation to provide product users with warnings about the products’ potential hazards. It provides that sophisticated users need not be warned about dangers of which they are already aware or should be aware. Because these sophisticated users are charged with knowing the particular product’s dangers, the failure to warn about those dangers is not the legal cause of any harm that product may cause. The rationale supporting the defense is that the failure to provide warnings about risks already known to a sophisticated purchaser usually is not a proximate cause of harm resulting from those risks suffered by the buyer’s employees or downstream purchasers. This is because the user’s knowledge of the dangers is the equivalent of prior notice.

In California, a manufacturer is not liable to a sophisticated user of its product for failure to warn of a risk, harm, or danger, if the sophisticated user knew or should have known of that risk, harm, or danger. An objective test applies, because it would be nearly impossible for a manufacturer to predict or determine whether a given user or member of the sophisticated group actually has knowledge of the dangers because of the infinite number of user idiosyncrasies. Hence, even if a user was truly unaware of a product’s hazards, that fact is irrelevant if the danger was objectively obvious to the expert user. And, the defense applies to both negligence and strict liability causes of action.

Here, Walkowiak’s own deposition testimony supported the finding that he was a sophisticated user of pyrotechnics. He had a Class 2 Pyrotechnic Operator license and years of experience in special effects. He knew that the SSM was a controlled pyrotechnic device and potentially dangerous. He understood the nature of the warnings provided on and with the SSM. He knew to ask for instructions on how to operate the device, and in fact asked for some information. In other words, said the court, Walkowiak knew or should have known of the risk involved in use of the SSM.

That Walkowiak did not have experience using the SSM and could only use it under supervision did not establish that he was unaware of the risks associated with its use. His testimony established that he was aware of the risks: he knew the SSM was dangerous, and he understood the nature of the warnings on the device, “Remove Before Ignition” and “This Side Up.” He simply did not know how to use the SSM with the shoulder launcher. Plaintiff could cite no authority, however, that would require a manufacturer not only to apprise a user of the risks associated with use of its product but also to provide instruction on how to use the product in a device it did not manufacture.

(The court remanded the design defect claim, under the risk benefit test, as the trial court had jumped the gun on its conclusion that an alternate design would make the SSM unsuitable for other uses.)

One of the fascinating and disturbing things about failure to warn claims is the endless supply of creative, far-fetched, fantastic, implausible, fanciful, incredible, questionable, even bizarre theories that plaintiff lawyers sometimes come up with to support this type of claim.

Last week, a Pennsylvania appeals court rejected just such a theory. Specifically, plaintiff alleged that a failure to warn caused her injury -- nothing strange there. But the manufacturer DID warn specifically of the condition she developed. So, what was the plaintiff's failure to warn theory? That a drug maker may be liable for failure to warn despite warning of the condition plaintiff developed, because a warning about a different medical issue —one that she did not develop— would somehow have caused her doctor to not prescribe the drug. Cochran v. Wyeth Inc., 2010 WL 2902717 (Pa. Super. Ct., 7/27/10).

Plaintiff ingested the prescription weight-loss drug dexfenfluramine, which was manufactured by Wyeth and sold under the brand name Redux. Wyeth informed the prescriber that Redux may cause primary pulmonary hypertension (“PPH”). The doctor, in turn, warned plaintiff of the risk of PPH prior to prescribing her Redux. At the time of his decision, however, the prescriber claimed he was unaware of the risk that Redux may cause valvular heart disease (“VHD”). Later, plaintiff was diagnosed with PPH, which she had been warned about. But she claimed that the doctor would not have prescribed Redux to her had he been warned that Redux could cause VHD.

Proximate cause is an essential element in a failure to warn case. A proximate, or legal cause, is defined under Pennsylvania law as a substantial contributing factor in bringing about the harm in question. That is, a plaintiff must establish proximate causation by showing that had defendant issued a proper warning to the learned intermediary, he would have altered his behavior and the injury would have been avoided. Wyeth argued that even if its warnings with regard to VHD were inadequate, its failure to warn of VHD was not the proximate cause of plaintiff's PPH. To establish proximate causation, plaintiff must prove that the warnings failed to disclose the risk of her particular injury (PPH).

The trial court agreed. On appeal, the court found an absence of clear authority on the issue, but strong guidance in those cases that have addressed a plaintiff's burden of proving proximate causation in the informed consent context. Finding the torts of informed consent and failure to warn analogous, the superior court was persuaded by those jurisdictions that have concluded a plaintiff cannot establish proximate causation where the non-disclosed risk never materialized into an injury.

Here, the risk of VHD did not develop into the actual injury of VHD. Although the prescriber testified in deposition that he would not have prescribed Redux had he known of the risk of VHD, this does not alter the fact that while Wyeth allegedly failed to disclose the risk of VHD the plaintiff suffered from PPH. In these circumstances, the relationship between the legal wrong (the alleged failure to disclose the risk of VHD) and the injury (PPH) was "not directly correlative and is too remote" for proximate causation.

Sean P. Wajert is a partner at Shook, Hardy & Bacon LLP. He concentrates his complex litigation practice on the defense of companies from a variety of industries, including the chemical, consumer product, drug and medical device industries. His practice...More...